The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex Human Placental Lactogen.
Device ID | K840588 |
510k Number | K840588 |
Device Name: | AMERLEX HUMAN PLACENTAL LACTOGEN |
Classification | Radioimmunoassay, Human Placental Lactogen |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JMF |
CFR Regulation Number | 862.1585 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-09 |
Decision Date | 1984-04-04 |